> ## Documentation Index
> Fetch the complete documentation index at: https://docs.hi-doctor.ai/llms.txt
> Use this file to discover all available pages before exploring further.

# Testosterone replacement

> Testosterone replacement is EU-authorised for confirmed deficiency only — the TRAVERSE cardiovascular trial and the 2015 EU review that restricted its use.

Testosterone replacement tops up the body's own supply of the hormone when
the testicles, or the glands controlling them, are not making enough. The
hormone then acts on androgen receptors in muscle, bone, brain and sexual
tissue.

<Note>
  Testosterone replacement is authorised in the EU, and a licensed doctor can
  prescribe it after a medical review when it is clinically appropriate for
  you.
</Note>

## What it is

Testosterone replacement is an authorised medicine in the EU. It is one of
the options a doctor may consider for sexual health, alongside the
PDE5-inhibitor tablets and topical alprostadil covered elsewhere in this
library.

<Warning>
  **Only authorised where deficiency is confirmed.** Following an EU-wide
  review that opened on 10 April 2014 and closed with the CMDh position of
  8 January 2015, product information was changed to state that testosterone
  should only be used when an abnormally low hormone level has been confirmed
  by signs and symptoms and by appropriate laboratory tests. The EMA states
  that restoring levels in healthy older men is not an authorised use — so it
  is not prescribed simply on request.
</Warning>

## What the studies reported

<Tabs>
  <Tab title="TRAVERSE (cardiovascular safety)">
    In TRAVERSE, a first cardiovascular death, non-fatal heart attack or
    non-fatal stroke occurred in 182 men on testosterone (7.0%) and 190 on
    placebo (7.3%) — hazard ratio 0.96, 95% CI 0.78 to 1.17, meeting the
    trial's non-inferiority criterion (Lincoff et al., N Engl J Med 2023).
    TRAVERSE also reported a higher incidence of atrial fibrillation, acute
    kidney injury and pulmonary embolism in the testosterone group than in
    the placebo group.

    <Warning>
      These results come only from men aged 65 and over whose low testosterone
      was confirmed by blood tests. They say nothing about men with normal
      testosterone levels, and the trial authors state the study was too small
      to draw conclusions about the risks of treatment.
    </Warning>
  </Tab>

  <Tab title="The Testosterone Trials">
    Snyder et al., N Engl J Med 2016 —
    The Testosterone Trials; Cunningham et al., J Clin Endocrinol Metab 2016 —
    Sexual Function Trial detail ([ClinicalTrials.gov · NCT00799617](https://clinicaltrials.gov/study/NCT00799617)).
  </Tab>
</Tabs>

Every NCT identifier links to its ClinicalTrials.gov record ([NCT03518034](https://clinicaltrials.gov/study/NCT03518034)
for TRAVERSE). A readout is not the same as peer-reviewed publication, and
results are grouped by source and evidence grade so journal data and
manufacturer announcements cannot be confused.

Sources: [EMA — Testosterone-containing medicines referral](https://www.ema.europa.eu) (nationally
authorised; indication and monitoring wording); [EMA — No consistent
evidence of an increased risk of heart problems with testosterone medicines](https://www.ema.europa.eu).

## Who it is not suitable for

Testosterone replacement is not prescribed for men with normal testosterone
levels who simply want a boost — the EMA is explicit that this is not an
authorised use. It is considered only once low levels are confirmed by
symptoms and by laboratory testing, and the doctor also weighs the
cardiovascular signal seen in TRAVERSE (higher atrial fibrillation, acute
kidney injury and pulmonary embolism) before proposing it.

## Other sexual health options a doctor may consider

Where testosterone replacement isn't appropriate, or the concern is erectile
function rather than deficiency, a doctor may instead consider:

<CardGroup cols={2}>
  <Card title="Sildenafil (Viagra)" icon="pills">
    Phosphodiesterase-5 inhibitor. The doctor assesses it after ruling out
    cardiovascular contraindications.
  </Card>

  <Card title="Tadalafil 10/20mg" icon="pills">
    Long-acting PDE5 inhibitor, available in low doses for daily use or
    higher doses on demand.
  </Card>

  <Card title="Vardenafil 5/10/20mg" icon="pills">
    Alternative within the same class, sometimes better tolerated depending
    on the patient's profile.
  </Card>

  <Card title="Avanafil 50/100/200mg" icon="pills">
    Faster-acting PDE5 inhibitor, an option for selected patients based on
    medical judgement.
  </Card>
</CardGroup>

[Vitaros](/library/medicines/vitaros) (alprostadil cream) is a topical
option considered for patients who don't respond to PDE5 inhibitors or have
contraindications to them. A licensed doctor decides case by case — we never
prescribe without evaluation.

## Common questions

<AccordionGroup>
  <Accordion title="Can I get testosterone replacement if I have normal testosterone levels?">
    No. The EMA is explicit that restoring levels in healthy older men is not an authorised use. Testosterone replacement is considered only once low levels are confirmed by symptoms and by laboratory testing.
  </Accordion>

  <Accordion title="What does the TRAVERSE trial say about heart risk?">
    In TRAVERSE, a first cardiovascular death, non-fatal heart attack or non-fatal stroke occurred in 182 men on testosterone (7.0%) and 190 on placebo (7.3%) — meeting the trial's non-inferiority criterion. TRAVERSE also reported a higher incidence of atrial fibrillation, acute kidney injury and pulmonary embolism in the testosterone group. These results come only from men aged 65 and over whose low testosterone was confirmed by blood tests.
  </Accordion>

  <Accordion title="Why did the EU restrict testosterone prescribing?">
    Following an EU-wide review that opened on 10 April 2014 and closed with the CMDh position of 8 January 2015, product information was changed to state that testosterone should only be used when an abnormally low hormone level has been confirmed by signs and symptoms and by appropriate laboratory tests.
  </Accordion>

  <Accordion title="What alternatives does Hi-Doctor offer for sexual health?">
    A doctor may consider sildenafil, tadalafil, vardenafil, avanafil or Vitaros (alprostadil cream), depending on your history and what the doctor decides is clinically appropriate. See [Vitaros](/library/medicines/vitaros) for the topical alprostadil option.
  </Accordion>

  <Accordion title="How does a Hi-Doctor consultation for sexual health work?">
    The questionnaire covers symptoms, cardiovascular history, current medication and allergies. A registered doctor reviews the case personally and decides whether treatment is appropriate, which one, and at what dose.
  </Accordion>
</AccordionGroup>

## How Hi-Doctor handles it

The questionnaire covers symptoms, cardiovascular history, current
medication and allergies — see how [eligibility works](/essentials/how-it-works)
and how [safety checks](/essentials/safety) run. Sexual health is offered as
a one-off consultation; the cost is set out on [pricing](/essentials/pricing).
The medicine itself, if a doctor prescribes one, is paid separately at a
pharmacy.

## Start a consultation

<Card title="Sexual health consultation" icon="stethoscope" href="https://hi-doctor.ai/consultation/sexual-health/1">
  Answer the sexual health questionnaire and a registered doctor reviews it.
  They decide whether treatment is appropriate, which one, and at what dose —
  and declining is a normal outcome. See [what it costs](/essentials/pricing)
  and [how the review works](/essentials/how-it-works).
</Card>

<Warning>
  This page is reference information, not medical advice and not a prescription.
  Whether a medicine is appropriate for you is decided by a registered doctor
  after reviewing your consultation.
</Warning>